Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

APV30005 enabled Human Immunodeficiency Virus (HIV)‐infected participants who had received a Fosamprenavir (FPV)‐containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI‐experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

FPV Population (APV30001)

FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)

NFV Population (APV30001)

FPV +/- RTV + background regimen in participants who had received NFV in APV30001

FPV Population (APV30002)

FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)

NFV Population (APV30002)

FPV +/- RTV + background regimen in participants who had received NFV in APV30002

FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003

PI-Naïve Population (Other Studies)

FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study

PI-Experienced Population (Other Studies)

FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study

Total

Total of all reporting groups

Baseline Measures

FPV Population (APV30001)

NFV Population (APV30001)

FPV Population (APV30002)

NFV Population (APV30002)

FPV/RTV QD Population (APV30003)

FPV/RTV BID Population (APV30003)

PI-Naïve Population (Other Studies)

PI-Experienced Population (Other Studies)

Total

Number of Participants
[units: participants]

119

18

221

54

73

78

104

86

753

Age, Customized
[units: years]Mean (Full Range)

36.3
(17 to 70)

35.8
(22 to 54)

37.7
(19 to 69)

36.2
(26 to 63)

41.9
(27 to 58)

42.3
(24 to 71)

39.3
(21 to 75)

40.2
(19 to 60)

38.7
(17 to 75)

Gender
[units: Participants]

Female

36

9

63

23

9

12

24

22

198

Male

83

9

158

31

64

66

80

64

555

Race/Ethnicity, Customized
[units: participants]

White

34

1

109

14

59

56

44

77

394

Black

35

6

86

34

10

14

34

7

226

Asian

1

0

4

0

1

1

1

0

8

American Hispanic

49

11

16

2

3

7

23

2

113

Other: Race Not Specified

0

0

6

4

0

0

2

0

12

Number of Participants with the Indicated CDC Classification of HIV Infection
[1][units: participants]

Asymptomatic or lymphadenopathy

81

16

124

13

26

30

76

29

395

Symptomatic, not AIDS

17

1

48

23

21

24

23

18

175

Acquired Immune Deficiency Syndrome (AIDS)

21

1

49

18

26

24

5

39

183

[1]

The Centers for Disease Control and Prevention (CDC) 1993 classification system for HIV infection was based on three clinical categories (A, B, and C). Category A comprised asymptomatic acute or primary HIV infection or persistent generalized lymphadenopathy (lymphnode disease). Category B comprised symptomatic conditions not included in clinical categories A or C but attributed to a cell-mediated immunity defect or for which the clinical course or management was complicated by HIV infection. Category C comprised AIDS-defining conditions.

Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)

Measure Description

Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.

Time Frame

Baseline and Weeks 12, 24, 48, 60, 96, and 132

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.